Ferrante, J.M., Chen, P.H., & Kim, S. (2008). The effect of patient navigation on time to diagnosis, anxiety, and satisfaction in urban minority women with abnormal mammograms: A randomized controlled trial. Journal of Urban Health, 85, 114–124.

To examine the effectiveness of a patient navigator after a suspicious mammogram in urban minority women in improving the time to diagnosis, decreasing anxiety, and increasing satisfaction

Women with suspicious mammogram findings were identified from radiology logs and contacted to participate. Women were told that the hospital was conducting a study to better understand their experience, in order to blind participants. Patients were randomly assigned to control/usual care or usual care plus patient navigation (intervention group). The navigator provided patients with emotional and social support, helped make appointments and arrive for appointments, facilitated financial assistance applications, provided information on resources and support systems, and facilitated interaction with healthcare providers and staff. The navigator had a bachelor’s degree in social relations and previous experience in counseling and community outreach, and was previously a volunteer for a breast cancer support group. The navigator underwent additional training and had ongoing mentoring with an oncology social worker. Study instruments were administered at the time of study enrollment and one month after resolution—either determination of benign diagnosis or initiation of cancer treatment.

• The study reported on a sample of 105 female patients: 55 in the intervention group and 50 in the control group.
• Mean patient age was 50.1 years ± 11.6.
• Patients had suspicious mammography findings: 15 in the intervention group and 11 in the control group were diagnosed with cancer.
• Of the sample, 60% had no insurance, 59% were black, 28% were Hispanic, 32% were married, 76% had a high school education or less, 63% did not have a previous abnormal mammogram, 81% had no family history of breast cancer, and 52% had no regular source of primary care.

• Single site
• Outpatient setting
• Urban university hospital in Newark, NJ

Patients were undergoing the diagnostic phase of care.

A randomized, single-blind, controlled trial design was used.

• Zung Anxiety Self-Assessment Scale
• Satisfaction With Hospital Care Questionnaire

Women in the intervention group had a shorter time to diagnosis (p = 0.001). Women in the intervention group had significantly lower anxiety at follow-up (p < 0.001) and a significantly greater reduction in anxiety from baseline to follow-up (p < 0.001). Baseline anxiety scores were similar in both groups. While anxiety declined in the intervention group, in the control group, anxiety scores were increased at follow-up compared to baseline. Satisfaction scores were significantly higher in the intervention group (p < 0.001). There were no differences between groups in demographic findings, and results indicated that effectiveness of the intervention did not differ associated with demographic characteristics. The mean time to diagnosis was 14.3 days in the intervention group, compared to 33.9 days in the control group.

The use of a patient navigator was effective to improve timeliness of diagnosis, reduce anxiety, and increase satisfaction in this group of patients.

• The study excluded a high proportion of the potential study population who did not speak English, since the navigator did not speak a foreign language.
• Subgroup analysis based on ethnicity and other factors may not have detected differences due to the small sample sizes in these subgroups.
• There was an overall low enrollment rate (36%) of the eligible population; this suggests that findings may be biased by self-selection of the study participants.
• There was no ability to compare study results to those in the general population who did not participate.

Findings show that patient navigation is an effective strategy to improve timeliness of diagnosis, anxiety, and satisfaction in a group of poor urban minority patients. Findings also show that many of these types of patients refused to participate, suggesting predominance of issues such as mistrust in this population. This suggests that assistance to this group of patients remains a challenge. Future research in this area needs to incorporate mechanisms to study those patients who also do not speak English. Larger sample sizes in this area of research are needed to further examine differences in outcomes based on demographic characteristic of potential relevance.